Although the placebo response proved better than expected in Chiasma Inc.'s phase III trial of Mycapssa (octreotide) capsules for acromegaly, "we believe that the response of the patients on Mycapssa is the clinically relevant indicator," said William Ludlam, the Waltham, Mass.-based firm's senior vice president of clinical development and medical affairs.

Given how many patients who completed the double-blind portion of the study opted into the extension segment and the quality of pharmacokinetic (PK) data, phase III testing of Intec Pharma Ltd.'s Accordion Pill (AP, carbidopa/levodopa [CD/LD]) against immediate-release CD/LD in Parkinson's disease (PD) seemed likely to ring the statistical significance bell.

Drug "re-innovation" specialist Bioxcel Therapeutics Inc. is gearing up to discuss a pivotal phase III trial for BXCL-501 with the FDA after top-line results of a phase Ib study showed it reduced schizophrenia-associated agitation while calming trial participants without excessive sedation. H.C. Wainwright & Co. analyst Raghuram Selvaraju called the results "highly favorable" and suggested the drug, a sublingual-formulated version of dexmedetomidine, could reach market as soon as 2021.

DUBLIN – Shares in Polyphor AG dropped as much as 21% Wednesday as the company shut down two phase III trials of its lead drug candidate, murepavadin, a first-in-class intravenous antibiotic in development for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

Positive data from one clinical trial evaluating lumateperone in patients with bipolar disorder wasn't enough to lift Intra-Cellular Therapies Inc.'s stock Monday as another trial's failure with the same drug severely dampened the price of shares, while analysts took the long, more optimistic view.

PERTH, Australia – Adelaide, Australia-based Bionomics Inc. reported another trial failure with its lead compound, BNC-210, in elderly patients with agitation, but it is still clinging on to hopes that the compound will show a clinical benefit for post-traumatic stress disorder (PTSD).

The artificial pancreas represents a dramatic improvement over existing approaches to management of diabetes, but Sernova Corp. of London, Ontario, is intent on going one better on conventional device technology. The company recently presented the results from an early phase study of its Cell Pouch device with pancreatic islet cells to a major medical conference, and the results suggest that the Cell Pouch with islets will pass the safety bar and may prove efficacious for several measures, including glycemic control.

Academic sponsors of clinical trials in the EU are the worst offenders when it comes to not posting completed trial results in the EudraCT database.

Boston Biomedical Inc. shuttered phase III study Canstem111P of napabucasin for patients with metastatic pancreatic ductal adenocarcinoma, adding to the list of studies that have fallen in pancreatic cancer.

Adding I.V. sildenafil – the active ingredient in Viagra – to inhaled nitric oxide (iNO) therapy for newborns with persistent pulmonary hypertension (PPHN) failed to achieve a statistically significant reduction in treatment failure rates or time on iNO vs. iNO alone in the first part of a phase III study sponsored by Pfizer Inc.